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Dr Reddy’s receives DCGI approval to conduct phase 2/3 trials of Sputnik V vaccine in India

It is unclear at this stage how many participants will be enrolled in this trial and how many sites will be studying the vaccine's safety and ability to help develop an immune response against Covid-19.

Written by Prabha Raghavan | New Delhi | Updated: October 18, 2020 12:36:47 am
coronavirus vaccine, russia corona vaccine, FDA guidelines on vaccines, US Vaccine, covid 19 vaccine india, Indian ExpressA view of a vial of Russia's experimental Sputnik V coronavirus vaccine. (Photo: AP)

Dr Reddy’s Laboratories (DRL) has received regulatory approval from the Drugs Controller General of India (DCGI) to conduct mid- to late-stage human trials for Russia’s Sputnik V vaccine candidate in India, the company said Saturday.

Delhi-based Mankind Pharma is also close to announcing an agreement to market and distribute the Russian Covid-19 vaccine here, The Sunday Express has learnt.

The developments bring India a step closer to potentially getting a Covid-19 vaccine by the end of this year.

Hyderabad-headquartered DRL, which tied up with the Russian Direct Investment Fund (RDIF) last month to help test and distribute Sputnik V in India, will now move ahead with an adaptive phase 2/3 clinical trial of the candidate here.

Explained

One step closer

The developments finally allow for testing of a candidate that, if found to be safe and effective here, could potentially bring India closer to receiving a Covid-19 vaccine by the end of this year. While the agreement with RDL could provide vaccines for 100 million people, any additional tie-ups like the potential agreement with Mankind could supplement this and cover a larger population.

“This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study,” Dr Reddy’s told the BSE in a filing on Saturday evening. Testing here is likely to involve around 1,500 participants across at least 10 sites, including those in Maharashtra, Andhra Pradesh and Telangana, The Sunday Express has learnt.

“The company’s revised protocol was approved by the Subject Expert Committee on Thursday,” said a source.

“(DRL) will conduct the phase 2 trial on 100 subjects, following which the data will be submitted to CDSCO (India’s top drug regulatory body). If the data is satisfactory, the trials can proceed to phase 3 on 1,400 subjects,” they added.

Once testing is completed and if approvals are granted, RDIF will supply around 100 million doses of Sputnik V to DRL. Unlike other two-dose vaccines, this would mean 100 million people in India would get the vaccine, as each “dose” contains two shots of different common cold adenoviruses, RDIF’s spokesperson had earlier told The Sunday Express.

It is unclear how many doses Mankind Pharma would be distributing as part of its agreement with RDIF. “(The company) has resources to manufacture (the vaccine) in South Korea and Israel,” said a source directly “However, this agreement would be for marketing and distribution,” the person added.

Sputnik V is also currently undergoing phase 3 clinical trials in Russia with a proposed number of 40,000 subjects. Additionally, phase 3 clinical trials of the vaccine also commenced in the UAE last week. “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” said G V Prasad, Co-chairman and Managing Director of DRL.

“This data will further strengthen the clinical development of Sputnik V vaccine in India,” said Kirill Dmitriev, CEO of RDIF.

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